| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 218663 | ANDA | CONCORD BIOTECH LTD | 001 | TERIFLUNOMIDE | TABLET;ORAL | 7MG | TERIFLUNOMIDE | 2025-04-07 | Prescription | No | |
| 002 | TERIFLUNOMIDE | TABLET;ORAL | 14MG | TERIFLUNOMIDE | 2025-04-07 | Prescription | No | ||||
| 213112 | ANDA | CONCORD BIOTECH LTD | 001 | TACROLIMUS | CAPSULE;ORAL | EQ 0.5MG BASE | TACROLIMUS | 2020-11-10 | Prescription | No | |
| 002 | TACROLIMUS | CAPSULE;ORAL | EQ 1MG BASE | TACROLIMUS | 2020-11-10 | Prescription | No | ||||
| 003 | TACROLIMUS | CAPSULE;ORAL | EQ 5MG BASE | TACROLIMUS | 2020-11-10 | Prescription | No | ||||
| 212087 | ANDA | CONCORD BIOTECH LTD | 001 | MYCOPHENOLATE MOFETIL | TABLET;ORAL | 500MG | MYCOPHENOLATE MOFETIL | 2020-07-31 | Prescription | No | |
| 211173 | ANDA | CONCORD BIOTECH LTD | 001 | MYCOPHENOLATE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 180MG BASE | MYCOPHENOLATE SODIUM | 2019-12-13 | Prescription | No | |
| 002 | MYCOPHENOLATE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 360MG BASE | MYCOPHENOLATE SODIUM | 2019-12-13 | Prescription | No | ||||
| 210181 | ANDA | CONCORD BIOTECH LTD | 001 | MYCOPHENOLATE MOFETIL | CAPSULE;ORAL | 250MG | MYCOPHENOLATE MOFETIL | 2019-01-08 | Prescription | No |